Facilitating enterprise wide EU-MDR compliance to continue sale of products in the EU
November | 2020
Client Background
Challenges
The new EU MDR Regulation 2017, with newer and stricter regulations / rules, makes it challenging to register legacy products in the EU. The scope of this project was to perform a gap assessment on the new EU MDR and then remediate the gaps. Wipro was chosen to perform a gap assessment and remediation of more than 1,000 products from a large legacy product portfolio. These gaps were in several areas such as design, quality, risk management, labeling, clinical evaluation, and post market surveillance. Remediation activities included creation of design history files, position papers, justification memos, specification development, test method development, verification plans / protocols, testing, and validation.
The key challenges were:
Solution
Key aspects of the solution included:
Business Impact
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© 2021 Wipro Limited |
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© 2021 Wipro Limited |
Pharmaceutical & Life Sciences